An inspection from a regulatory body who has the authority to shut down your business putting a halt on production can be as nerve-racking as the stress of the day you get married! You are absolutely married to your lab by the way. The lab may not need something borrowed, something blue, something old, or something new, but there are absolutely three elements needed to keep you from fainting at the proverbial altar on inspection day: infrastructure, equipment, and compliance.
The path to a successful engagement in this endeavor is proper planning and design, project management, and a vast understanding of the operator’s rules in your market. Once success is achieved, constant process improvement along with internal auditing and employing the right team of intellectuals will help your operation thrive into continual sustainability.
Infrastructure
It does not matter what type of cannabis/hemp facility you are planning to construct, whether it be a cultivation facility, processing/manufacturing facility, or a testing laboratory — this is the MVP of the license application. You cannot gain approval with just a solid business plan. You will have to show the regulatory agency in your state that you are serious and understand how to build safety and compliance into your business starting with the tangible structure itself.
Serious consideration and visualization of the entire operation from seed to shelf must translate to the facility planning and design phase in the layout. You will need to meet with an experienced architect, engineer, general contractor, and city officials to determine the best path forward in achieving compliance for an operational license. These subject-matter-experts (SME) play integral roles in the launch of the build-out project and guide you to earning your Certificate of Occupancy (CO), which is a component necessary for earning your license. Local agents including but not limited to the Fire Marshal will need to ensure your facility is safe and in proper operating conditions for employees.
The architect and process engineers will be instrumental in the design and layout of the facility. They will consider the equipment specifications from an electrical, plumbing, ventilation, and mechanical perspective. For example, if you are planning to construct a fully indoor cultivation facility with butane extraction, you will need to contemplate the airflow in the grow rooms as well as construct a class 1 division 1 (C1D1) environment for biomass extraction. Process flow is an especially important aspect of facility design as well since a huge piece of the application is demonstrating safety for all employees. Harvesting material in one location and having to go through the processing rooms to reach the dry/cure areas does not make sense for process flow optimization. It may sound ridiculous, but please believe there are many facilities with horrid designs causing safety hazards, less productivity, and overall confusion of staff.
Equipment
Sitting with the initial planning and design team, hammering out the details of how the facility should look and operate, is the first major step. The next step is to engage a consultant with previous experience about equipment selection. As a consultant and licensed project manager, I am typically engaged from the very beginning during the previous phase to ensure the equipment collection is aligned with facility design. For instance, terpene extraction using certain industrial equipment requires unique electrical set ups. It is awfully expensive to realize the supplied electrical for a piece of equipment is neither supplied nor sufficient, prompting a change order to install a buck-boost transformer to step up 208VAC to 230VAC. Sometimes outlet types are different from your standard GFCI-15 outlet as well, e.g., a NEMA 6-15 plug.
During the planning and design phase, it’s important to gather as many technical specifications as possible for every piece of equipment to operate in your facility. This will inform the design team of all factors necessary to mitigate potential risks or missteps later in the build out.
Compliance
Oh, what a feeling it is to achieve an operational license in a legal cannabis/hemp market! I would compare the feeling to having your first child, spending day in and day out nurturing the growth of that being. Eventually, the child grows and starts to scoot, crawl, walk, then run, requiring less of your constant attention. The fundamentals have been instilled, and continuous monitoring while polishing adds to their success in becoming a functioning member of society.
Similarly, this is the same progression once you’ve built the facility, earned your CO, and passed the regulatory inspection. The cherry on top of achieving the operational license is how well you adhere to complying with your local and state rules for cultivation, processing, and testing. Most states have mandated a level of food safety due to the human consumption of cannabis products. Setting up quality control programs that adhere to Good Manufacturing Practices (GMP) in cultivation and processing facilities is key to ensuring a safe product is being produced from your business. GMP compliance is somewhat facility and equipment, but substantially documentation, training, and quality assurance. Making sure you have standard operating procedures (SOP) for every process, a quality assurance program, and robust training schedules for all staff will ensure a successful state inspection. An experienced consultant should give you trusted and vetted SOPs littered with compliance items as well as help you develop a training program, schedule, and documentation to run your operation in a sustainable manner.
In contrast, a testing laboratory’s compliance piece is different due to providing an ancillary service and not an ingestible product. Most testing laboratories seek to achieve ISO 17025 compliance, which ensures the repeatability and robustness of the methods being used to analyze products. The testing laboratory must demonstrate instrument operator capability along with specified SOPs for method development and sample analysis. All methods used should be validated and documented establishing appropriate limits of quantitation (LOQs) coinciding with state action limits.
Conclusion
Whether these components of preparing for the big day are put to use on the first day of your relationship with the business or the middle of the expansion of your operation, they are all imperative to sustaining your operational license. After the regulatory bodies that hold the key to you heart say “I DO,” giving you the operational permission to conduct business, the step you take next is that of crossing the threshold of continuous process improvement.
